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目的采用纳米分散技术制备非诺贝特胶囊剂,以提高其溶出度及生物利用度。方法用反溶剂沉淀法和高压匀质法制备非诺贝特纳米混悬剂,并通过喷雾干燥将其固化以制备胶囊剂,用差示扫描量热法(differential scanning calorimetry,DSC)和X-射线粉末衍射分析表征药物在胶囊剂中的存在状态,并测定药物的溶出度及家犬体内的生物利用度。结果非诺贝特以纳米晶体状态分散于胶囊剂中,自制胶囊溶出度为国产胶囊的3倍,相对生物利用度为国产胶囊的(274.5±15.6)%。结论自制非诺贝特胶囊剂可以通过增加非诺贝特的分散度来提高药物的溶出度与生物利用度。
OBJECTIVE To prepare fenofibrate capsules by nanodispersion technique to improve their dissolution and bioavailability. Methods Fenofibrate nanosuspensions were prepared by antisolvent precipitation and high pressure homogenization and cured by spray drying to prepare capsules. Differential scanning calorimetry (DSC) and X- Ray powder diffraction analysis characterizes the presence of the drug in capsules and measures the dissolution of the drug and the bioavailability in dogs. Results Fenofibrate was dispersed in capsules in nanocrystalline state. The dissolution rate of homemade capsules was 3 times that of domestic capsules, and the relative bioavailability was 274.5 ± 15.6% for domestic capsules. Conclusion Homemade fenofibrate capsules can improve drug dissolution and bioavailability by increasing the dispersion of fenofibrate.